What is MIRS?

De Young & Hayden, LLC, are experts in helping biopharma executives to create MIRS documents
that effectively and succinctly strengthen, focus and guide biopharmaceutical developments. The
MIRS concept is the basic intellectual process underscoring decision-making in biopharmaceutical
development.

Messages: statements establishing company positions, such as target labeling
Issues: development obstacles, regulatory or market hurdles
Response: appropriate scientific logic and study design
Support: quantifiable data as the base of support

The product of the MIRS process is a scientific knowledge matrix that presents a decision-making
portrait of a potential moment in time. It identifies cross-functional input and links to provide a
common repository for the key features of the product and how these features can be presented
and supported.

A MIRS document provides an ongoing record of current information on the product as well as
recording strategies for addressing concerns.  In addition, MIRS identifies Messages that are yet to
be proven but that represent the target for product development.  By proactively identifying Issues
as well as the necessary rationale and Support, the MIRS process can ensure that study designs
and data collection are guided by the goals of development.

    "The MIRS approach that DYH used during the development of our market preparation
    messages provided an easy-to-follow framework for the many different stakeholders in the
    process. The rigor behind the process helped significantly to build a solid message platform
    during this critical time of the product launch."

    Neville Kodkani, M.D., M.B.A.
    Product Director, Commercial Operations
    Hoffmann- La Roche Inc.

    "The MIRS process is an invaluable tool that can significantly reduce writing and reviewing
    time.

    It allows the writer, and hence the reader, of any document to get to build a solid logic and
    get to the point quickly. MIRS allows transparency of content in documents .To not use the
    MIRS process is to invite inefficiencies into your writing process."

    Joan Barton
    V.P. of Risk Management and Compliance
    The Medicines Company